Somatostatin analogues as a volume reducing treatment of polycystic livers - SOLVE

Phase 1

• Conditions: Polycystic liver disease, due to isolated polycystic liver disease or polycystic kidney disease.; MedDRA version: 12.1Level: LLTClassification code 10036048Term: Polycystic kidney, unspecified type; MedDRA version: 12.1Level: LLTClassification code 10048834Term: Polycystic liver disease; MedDRA version: 12.1Level: PTClassification code 10048834Term: Polycystic liver disease; MedDRA version: 12.1Level: LLTClassification code 10036045Term: Polycystic kidney; MedDRA version: 12.1Level: LLTClassification code 10036046Term: Polycystic kidney, autosomal dominant

• Registration Number: EUCTR2009-017849-57-NL
• Lead Sponsor: Radboud University Nijmegen Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-13
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients with ADPKD with polycystic liver (> 20 liver cysts)
• At least 18 years of age
• Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Kidney transplantation
• Renal failure requiring hemodialysis
• Proteinuria of > 1g/L at baseline
• Use of oral contraceptives or estrogen suppletion
• Women who are pregnant or breastfeeding
• History of cardiac/pulmonary disease; symptomatic gallstones, etc
• Intervention (aspiration or surgical intervention) within three months before baseline
• Mental illness that interferes with the patient ability to comply with the protocol
• Drug or alcohol abuse within one year of baseline

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Reduction of liver volume;Secondary Objective: Reduction of kidney volume, symptom evaluation, monitoring of kidney function;Primary end point(s): reduction of liver volume